Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
Background: Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can also affect travelers who have never been exposed to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine, antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited under a general screening study in order to see if are qualified to join a future malaria study. Objective: To screen healthy volunteers to see if they are eligible to join investigational malaria studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines, or prevention regimens. They may also involve controlled human malaria infection trials. Eligibility: Healthy people ages 18 50 Design: Participants will first be prescreened by phone. Participants will be screened with: Medical history Physical exam Blood and urine tests Participants may go more than 1 year without joining a clinical trial. If this happens, they may be re-contacted to see if they still want to be part of this screening protocol. Those who still want to participate and have had relevant medical changes will be rescreened.
Description
This is a screening protocol for healthy volunteers to participate in research studies conducted by Laboratory of Malaria Immunology and Vaccinology (LMIV). Malaria-related morbidity and mortality have a major economic impact in endemic regions and present a substantial health risk to non-immune travelers and people living in endemic areas. To stem the worldwide impact of this devastating disease, a safe and broadly effective malaria vaccine and improved antimalarial therapeutics are urgently required. This screening protocol is designed to continuously evaluate potential healthy volunteers…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: All of the following criteria must be fulfilled for a subject to participate in this trial: 1. Age \>= 18 and \<= 50 years. 2. In good general health and without clinically significant medical history 3. Reliable access to the clinical trial center and available in the area for more than 1 year 4. Females of childbearing potential must be willing to undergo periodic pregnancy testing and use reliable contraception per protocol when enrolled into LMIV clinical trials (protocol-specific requirements) EXCLUSION CRITERIA: A subject will be excluded from participating in t…
Location
- National Institutes of Health Clinical CenterBethesda, Maryland